ELECTRONIC PRODUCT INFORMATION: FROM PRINCIPLES TO ACTIONS - AESGP, EFPIA and Medicines for Europe reflections on EMA- HMA - EC Key principles for ...
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ELECTRONIC PRODUCT INFORMATION: FROM PRINCIPLES TO ACTIONS AESGP, EFPIA and Medicines for Europe reflections on EMA- HMA – EC Key principles for electronic product information
Contents
Reader Guidance 4
Executive summary 5
ePI: Drivers and benefits for all stakeholders 6
The way forward to move from principles to action 7
Key Asks 9
Introduction 10
Definitions 11
Benefits for Public Health 13
Efficiency gains for regulatory systems 15
Existing legislative framework 16
Processes, flexibility and Governance 17
Multilingual ePI 18
Interoperability with EU and global initiatives 19
Annexes 20
Annex 1: Definitions 21
Annex 2: Benefits for Public Health 23
Annex 3: Efficiency gains for regulatory systems 26
Annex 4: Existing legislative framework 28
Annex 5 Processes: High-level Governance & Flexibility in Implementation 31
Annex 6: Multilingual ePI 34
Annex 7: Interoperability with EU and Global initiatives 35
Abbreviations and Glossary 36
Contacts 39
2
EXECUTIVE SUMMARY
3
Reader guidance
Reader guidance
The document is structured with an opening ‘executive summary’ which summarises the drivers for
ePI and the benefits for all Stakeholders, the way forward to move from principles to action and the
key asks.
The following paper includes the content and key points from the individual sections which relate to
the EMA Key Principles guidance document.
In addition to the paper, there are a series of seven stand-alone annexes, that provide more in-depth
detail that can be used separately in discussion or as an integrated document about the ePI Key
Principles. At the end of each section is a ‘Call for Action’ which is a practical list of recommended
actions to be initiated.
4
Executive summary
Electronic product information: from Principles to actions
The European Medicines Agency (EMA), the Heads of Medicines Agencies (HMA) of EU Member States and the European
Commission (EC) have published in 2020 the key principles paper outlining a common approach to develop and use
electronic product information (ePI) for human medicines across the European Union1.
The pharmaceutical industry fully supports the provision of comprehensive, accurate and up-to-date regulator-approved
information on medicinal products, both for patients and healthcare professionals (HCPs) and EMA/HMA’s conclusion that
there is a need to explore alternative innovative pathways of disseminating information in electronic format.
The value of ePI has been clearly recognised in the European Medicines Regulatory Network Strategy2 (EMRN) where
multiple benefits for patients’ empowerment, operational excellence and sustainability of the Regulatory Network have
been envisaged for the healthcare and pharmaceutical environment.
Also, the European Parliament (EP) has called for the urgent implementation of ePI “in order to facilitate the moving and
sales of medicines within the single market and thus mitigate shortages” in the EP Report on shortages3.
Moreover, the recent European Pharmaceutical strategy4 has highlighted how the “better use of product information in
electronic format (ePI) could facilitate the delivery of information on the medicine to healthcare professionals and patients
in the EU’s multilingual environment and support wider availability of medicines across Member States”. In the next years,
the European Commission (EC) will collaborate with Member States and industry “to develop and implement electronic
product information (ePI) for all EU medicines” and “evaluate and revise relevant provisions in the legislation by 2022”.
Moreover, the need for flexibility by using ePI was recognized in the context of the preparedness work of COVID-19 vaccine
development and the associated logistics of early printing packaging activities.5
This paper provides the industry views on the ‘Key Principles’ document but also provides a holistic vision of what
is needed to deliver timely and easily accessible and up-to-date medicinal product information to patients and
HCPs, contributing to the overall health literacy of EU Citizens.
1 https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/electronic-product-information-human-medicines-european-union-key-principles_en.pdf
2 EP REPORT on the shortage of medicines – how to address an emerging problem (2020/2071(INI)), para 75.
3 https://ec.europa.eu/health/sites/health/files/human-use/docs/pharmastrategy_com2020-761_en.pdf
4 https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/electronic-product-information-human-medicines-european-union-key-principles_en.pdf
5 https://www.ema.europa.eu/en/documents/other/questions-answers-labelling-flexibilities-covid19-vaccines_en.pdf
5
ePI: Drivers and benefits for all stakeholders
All stakeholders (patients, healthcare professionals, caregivers, regulators and industry) can benefit from ePI implementation.
The needs of the patient and HCPs (the ultimate end-users) must be at the forefront of the EC/EMA/HMA ePI
implementation strategy and approach.
HEALTH HEALTH CARE
INDUSTRY PATIENTS ENVIRONMENT
AUTHORITIES PROFESSIONALS
• Mitigation of shortages • Improved access to tailored information on • Less waste of paper
• Efficiency gains for regulatory systems end-user needs leaflet
and facilitating decision-making • Accessibility to user with diverse abilities
• Enhancing knowledge of trends in • Advance health literacy
medicines and their evolution • Provision of the latest information on a
medicine’s safety, benefits and conditions of use
• Informed decision-making by patient/consumer
and HCPs
• Multi-linguale ePI
Industry believes that public health could benefit enormously from a coherent and consistent ePI implementation across
the EU. Considering new advanced technologies, we could and must go beyond the current scope proposed by the EMA
key principles.
Some examples of benefits and functionality that ePI could bring:
• Immediate access to the most recently regulator-approved product information.
• Attractive, presentable and user-friendly interface with other potential supportive features (e.g. user font modification)
would motivate patients to take a more active interest in their health status.
• Availability of additional materials to the statutory information: video and audio facilities6 accessible to support and
improve health literacy and safe use of the product.
• Alerts for major updates to the leaflet.
However, ePI will not solve issues encountered due to poor compliance or low literacy per se, so work on the content
(readability, user testing, QRD template, etc) and other related information such as instruction videos, audio content,
additional materials and risk minimisation materials will need to take place in parallel.
Efficiency for the Regulatory Network
• Automated Data filling from • Simplified Introduction of
systems (SPOR, supported by referral or health authority
ePI TOM) for structured data ePI requested safety change outcome
CREATION • Other sources for MAINTENANCE • Longer implementation time for
semi-structured data providing the updated paper
• Controlled vocabulary leaflet in the box
HOW Maintenance of text should be easier: as ePI is structured, only the update of the relevant section of the PI needs to be changed.
In case information needs to be changed in several places of the PI (e.g. product name), this could be done automatically.
Changes made directly into systems: will speed up the process for update and approval of any change to the PI
Update of the QRD requirements should be reflected in the system, leading to automatic update of the ePI in accordance with
the new version of the QRD
Regulatory efficiencies and operational excellence will be achieved for the benefit of regulators and industry via a harmonised
implementation of ePI across Europe. There are excellent opportunities for efficiencies with ePI in the regulatory system
6 https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/mobile-scanning-other-technologies-labelling-package-leaflet-centrally-authorised-medicinal-
products_en.pdf
6
through improved interoperability, ensuring better accessibility and a high level of regulatory compliance, by using structured
and semi-structured data. These regulatory processes should leverage existing data of the TOM facilitated SPOR system.
The Environment
The Green deal and the EU Commission agenda to improve the environment: we see a huge potential upside of
the ePI by successively replacing the paper leaflet, starting in the hospital setting and outside of the hospital setting with
products that are directly administered by HCPs (e.g. vaccines), to reduce the volume of paper and ink (and all associated
industrial activities) that are currently used. This will also contribute to the decrease of the Carbon footprint.
The way forward to move from principles to action
1. Need to collaborate at different levels of the pharmaceutical network to establish Governance model and
balance flexibility with patients and stakeholders needs
Industry has reached out for a strong collaboration with regulators and other stakeholders including the Telematics
Management Board, to ensure we gain the efficiencies in the processes while being conscious of the priority to improve
health information.
The programme for developing ePI must be aligned with all complementary EU telematics projects including eCTD,
SPOR, TOM, CESP Dataset Module, and Regulatory Optimisation of Variations, and be strongly positioned in the EU
Network Strategy. The ePI programme needs to be based on a solid governance structure and attribution of roles and
responsibilities in the ePI implementation.
There is a need for a robust milestone-driven roadmap that is aligned with the different stakeholders and which is
based on agreed use cases. The roadmap should be drafted with high priority given to the benefits of the patients; for that
reason, both new and existing products should be considered as part of the first milestone.
• To achieve these key objectives and meet these expectations, urgent and adequate funding is required to underpin the
project work.
• For a successful implementation of ePI across EU/EEA in the interest of the patients, technology and process have a
crucial role to play in achieving the goals.
• It would also be important to start urgently an open dialogue with industry and regulators to agree on how ePI will fit
into the future telematics ecosystem to ensure benefits for all end-users (such as patients, HCPs and carers).
• The ePI Key Principles paper suggests that a broad margin of flexibility is given for national implementation of ePI across
EU/EEA. However, this flexibility should be accompanied by a clear and binding phased roadmap and value-added
milestones that include a proof-of-concept phase in which the level of acceptable flexibility for an ePI approach can be
tested and improved accordingly.
2. ePI definition and common standard
The definition of ePI encompasses more than information for the prescriber and patients, it also includes labelling, blue box
requirements and Annex II information7.
The priority for delivering ePI should be the freely accessible provision of trusted (regulator-approved) information to patients,
consumers and HCPs. Therefore, we propose a phased approach, which starts with the creation, regulatory processing
and dissemination of electronic Package Leaflets (PL) and Summary of Product Characteristics (SmPCs); a mutually
agreed roadmap defines the subsequent addition of other value-adding aspects of ePI, plus corrective modifications (from
post-implementation learning).
One of the first key enablers for the adoption of ePI is a common standard that allows the generation and dissemination of
authorised information in the EU/EEA. Features such as vocabularies and interoperability specifications are considered
important for ePI.
3. Existing legislative framework to coexist with digital innovation
The EC Pharmaceutical Strategy8 formulates as an action to “develop and implement ePI for all EU medicines with involvements
of member states and industry”. In addition, it recognised the need to “evaluate and revise provisions in the legislation”.
Industry believes that the ePI shall have the same value as paper PL, however this evolution requires further practical
experience following the implementation of ePI and should be considered as part of the evaluation of the legislation.
There are situations where the paper PL could be removed from the pack and substituted by ePI while still ensuring
patients’ needs and interests are respected (e.g. by providing printed leaflet at point of dispensing).
Current practices with hospital / healthcare professional-administered products where patients rarely receive the
package leaflet, show there is no reason not to remove the paper leaflet from the pack. By directing patients toward the
ePI, it will fill the gap of information that is a reality in today scenarios.
Therefore, industry proposes to expand current national pilot9 into an EEA-wide pilot study to investigate the current
practices and benefits of replacing paper with ePI for hospital/HCP administered products. Such a pilot could be
expanded to products directly dispensed to (and used by) patients in highly digitalised markets to investigate the current
7 https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/electronic-product-information-human-medicines-european-union-key-principles_en.pdf ,
page 4.
8 https://ec.europa.eu/health/sites/health/files/human-use/docs/pharmastrategy_com2020-761_en.pdf, pages 15 and 16.
9 More information available at the following links: https://www.afmps.be/fr/news/projet_pilote_e_pil_la_notice_papier_fait_place_a_la_notice_electronique; The Ministère
de la Santé in Luxembourg website https://sante.public.lu/fr/actualites/2020/08/e-pil-call-for-candidates/index.html
7
practices for provision of information to patients and possible future alternatives such as the replacement of paper package
leaflets with ePI (or other alternatives, such as printing at pharmacy level).
Industry welcomes further discussion on additional ‘use cases’ that explore broader benefits of ePI considering:
• faster dissemination of relevant regulatory approved changes to product information
• mitigation of medicines shortages (by redistribution of packages in different languages)
• reduced packaging/distribution and wastage costs (arising from changes and recall of batches)
• immediate access to the latest information via ePI following approval, enabling a more flexible transitional period for the
provision of up-to-date paper leaflets
• possible removal of the paper leaflet to reduce the volume of packaging and use of paper and ink and decreased carbon
footprint
• efficiencies in the size of outer packaging materials thereby reducing transport and storage space, (especially important
for products requiring controlled temperature storage)
4. ePI as main source of product information
The availability of ePI in multiple languages will facilitate the mitigation of product shortages by enabling easier supply
without the need for relabelling. This is especially important in times of increased risk of medicinal shortages as observed
with the COVID19 pandemic. As recognised in the EU Pharmaceutical strategy ePI can “support wider availability of
medicines across Member States”.
Broader use of multilingual packages could increase availability of medicines and improve management of the
supply chain. However, due to the challenges in providing printed paper leaflets in all languages in the final packaged
product this is complex. ePI represents a game-changer tool to address this, if individual EU and EEA states will agree
to accept packaging potentially with one language only and have the other official approved language versions available
electronically. This would also facilitate the supply to small markets.
5. Access to ePI: intuitive and friendly for an informed decision-making by patients / consumers and HCPs
In the ePI key principles document, it is envisaged that “ePI will be made available to users (e.g. patients/consumers and
HCPs) through websites at EMA level and if available, Member State level. ePI data will be made available for use in other
e-health systems, such as electronic health records and e-prescribing systems. ePI will also be available for use by third-
parties, who can reproduce ePI and make it available to patients and HCPs (as is already the case for PI today)”.This is the
reason why “ePI should always be published as freely accessible open data” and will be accessible by third parties for
example, for use in websites and patient/consumer apps.
Industry understands the value of ePI being available on a range of platforms throughout the EU but most importantly each
Member State must follow a coherent and consistent approach to develop and use ePI (from the point of submission).
In addition, it is critical to have a safe and secure access to the correct ePI from the medicinal pack. This process should
be intuitive and as simple as possible.
We support the concept to have a single access-point to extract and re-use ePI as described in the Key principles –
process chart.
• Outer package: further discussion is needed in light of current and evolving technologies and standards, to facilitate one
code10 only on the (secondary) packaging to ensure clarity to patients, HCP and pharmacists and to avoid the risk of
mistakes and/or misunderstanding.
• The architecture of the web portal11 must be structured in a way that patients are smoothly and unequivocally directed
to the correct regulatory ePI, for that specific product.
• Patients who cannot access their product information electronically should have the same opportunity as those who
have (e.g. by providing printed leaflet at point of dispensing).
• An educational campaign to raise awareness on this new way of accessing information is key to its widespread
adoption as part of the informed decision-making process.
6. Interoperability by design
Industry welcomes the ePI principle of interoperability by design employed in other ongoing initiatives in the digital
environment such as eHealth initiatives and EU Telematics projects and recommends including it as a criterion the design
and implementation of ePI from the start. This will be essential to achieve significant objectives for patients and HCPs,
such as alert of significant changes in the PI content or specific, like safety measures, but also to achieve efficiencies in
the regulatory systems. SPOR data management service, current electronic application procedures and national ePI
systems represent the foundation of ePI for its effective implementation.
10 A code can be achieved using different technology including but not limited to QR codes, 2D data matrix codes, linear barcodes.
11 A pan-European medicines web portal providing a central point for access of ePI for all centrally and nationally authorised medicines (see EMA/HMA/EC paper
‘Electronic product information for human medicines in the EU: key principles’).
8
Key Asks
Launch the ePI project Identify a clear Governance structure and ownership of the ePI project, that will
take care of ensuring the appropriate funding, which is required to accelerate the
Governance/Guidance/Regulatory ePI development
An agreed binding Roadmap for a consistent and coherent ePI implementation in
all EU member States, covering all pharmaceutical products
Establish a central coordination of all “ePI like” initiatives
Start an open dialogue between regulators and industry in early 2021, to fit ePI
into the future telematics ecosystem
Active involvement of the telematics network, to ensure processes are more
efficient and linked to other relevant telematics projects
A future EU Implementation guideline elaborating on the concept of ePI, structured
and unstructured and re-usable elements should be provided by EMA
Develop a Common standard in collaboration between the Industry, Regulators
and impacted stakeholders
ePI interoperable by design should be a successful criterion for its coherent
implementation
Stronger collaboration between regulators and industry to establish the needs of
both in the Regulatory processes
Pragmatic way to include a standardised sentence in the paper leaflet, highlighting
the existence of an ePI on reference websites, and avoid any regulatory or
administrative burden to the system.
Architecture of the web portal (and any other access point) should be structured
in a way that patients are smoothly and unequivocally guided and directed to the
right ePI
Supporting stakeholder discussions on additional ‘use cases’ and the
positive benefits
Discussion between Industry and regulators must be undertaken on how to link
ePI with only one code on the (secondary) package
Policy and legal A transparent and open discussion, confirming “data stewardship(s) and data
ownership(s)” of the content of ePI
aspects
Expansion of Pilot projects investigating the benefit of replacing paper with ePI
for hospital/HCP administered products
Dialogue between industry and regulators on recognition of ePI as main source
in scenarios where it can mitigate shortages or increase availability of medicines
in small markets.
In future, removal of the paper on voluntary basis and ePI as single source will
facilitate multi-country packs
Conduct legal framework analysis, for the development of an ambitious
ePI roadmap
Patients and HCPs Educational campaign to raise awareness on ePI
Discussion on how to secure safe and easy access to ePI for patients
Collaboration of all stakeholders (patients, HCP, Industry, regulators) to define
how the content of the PI can be improved.
Recognise ePI as a part of the eHealth strategy
9
Introduction
The EU product information (PI) for medicinal products consists of two main documents: the Summary of Product
Characteristics (SmPC) and the Package Leaflet (PL), which are regulated regarding their content, structure, and layout. To
be effective, ePI has to be actively referred to, read, understood, trusted and remembered. The SmPC is primarily directed
to Healthcare Professionals (HCPs), while the PL addresses patients and caregivers, requiring different language and layout
principles to suit the reader.
The NIVEL study12 identified several shortcomings of the SmPC and PL, e.g. current layout (font size, line spacing, and
template), structure and length which may lead to unintended consequences, such as the patients not adhering to treatment.
Additionally, patients may become confused or worried, for example because of the extensive list of side-effects or a lack of
balanced benefit-risk information that would help them understand the benefits and potential consequences the medicine
would have on them13.
In response to the NIVEL study the European Commission in 2017 issued recommendations, to address the shortcomings
identified and subsequently the EMA released an action plan14 to implement the recommendations made. The
recommendations focus largely on improving content, layout and readability (including patient involvement) and electronic
formats of product information.
The pharmaceutical industry fully supports the provision of comprehensive, accurate and up-to-date regulator-approved
information on medicinal products, both for patients and HCPs. Such information must be safely and easily accessible,
allowing the patients/HCPs to obtain, identify and use the information necessary to meet their individual needs. Patients’
role in their own health care is changing from patient compliance to patient engagement. Therefore, the importance of
the product information is increasing, and content, readability and layout are considered key pillars for its correct and
appropriate use. Consequently, the pharmaceutical industry believes that the enhancement of product information content
is considered critical and should be further developed as part of a broader programme in building citizens’ health literacy in
partnership with patients, HCPs and authorities. The content should follow general health literacy principles in order to allow
individuals to access, understand, appraise and apply health information pertinent to themselves, so that they can make
appropriate and informed decisions15.
The pharmaceutical industry supports the EMA’s conclusion that there is a need to explore alternative innovative pathways of
disseminating information in electronic format. The use of existing and evolving technologies could allow immediate access
to the most recent regulator-approved ‘real-time’ product information, rather than relying on potentially out of date paper
copies or electronic information from non-trusted sources. This approach would enable patients to search trusted information
sources in a tailored fashion to meet their own needs. Furthermore, a direct link from the medicines packaging would
enhance accessibility without the need to rely on search engines pointing towards trusted sources of ePI.
Prioritisation has been given to the development of an electronic approach to the creation and dissemination of product
information in a structured format (ePI). EMA, the Heads of Medicines Agencies (HMA) of EU Member States and the
European Commission (EC) have published key principles outlining a harmonized approach to develop and use
electronic product information (ePI)16 for human medicines across the European Union. These principles represent a
collaborative guidance on ePI and form the basis of follow up implementation plans for ePI.
The value of ePI has been clearly recognised in the European Medicines Regulatory Network Strategy17 (EMRN), where
the multiple benefits for patients’ empowerment, operational excellence and sustainability of the Regulatory Network have
been envisaged for the healthcare and pharmaceutical environment. Recently, also the European Parliament (EP) in the
EP Report on shortages have called for the urgent implementation of ePI “in order to facilitate the moving and sales of
medicines within the single market and thus mitigate shortages”18.
Moreover, the recent European Pharmaceutical strategy has reinforced how the “better use of product information in
electronic format (ePI) could facilitate the delivery of information on the medicine to healthcare professionals and patients
in the EU’s multilingual environment and support wider availability of medicines across Member States”. The European
Commission (EC) will collaborate Member States and industry “to develop and implement electronic product information
(ePI) for all EU medicines” and “evaluate and revise relevant provisions in the legislation”19.
12 https://ec.europa.eu/health/sites/health/files/files/committee/75meeting/pil_s.pdf
13 https://ec.europa.eu/health/sites/health/files/files/committee/75meeting/pil_s.pdf at page 8 and 9
14 https://www.ema.europa.eu/en/documents/other/european-medicines-agency-action-plan-related-european-commissions-recommendations-product_en.pdf
15 Sørensen K, et al. Health literacy in Europe: comparative results of the European health literacy survey (HLS-EU). Eur J Public Health. 2015 Dec;25(6):1053-8.
16 https://www.ema.europa.eu/en/electronic-product-information-human-medicines-european-union-key-principles
17 https://www.ema.europa.eu/en/about-us/how-we-work/european-medicines-regulatory-network/european-medicines-agencies-network-strategy
18 EP REPORT on the shortage of medicines – how to address an emerging problem (2020/2071(INI)). Para 75
19 https://ec.europa.eu/health/sites/health/files/human-use/docs/pharmastrategy_com2020-761_en.pdf
10Definitions
The definition of ePI encompasses more than information for the prescriber and patients, it also includes labelling, blue
box requirements and Annex II information. This seems to be based on the current combined product information in PDF
format provided by EMA, which contains all annexes to the Commission Decision. The priority for delivering ePI should
be the freely-accessible provision of trusted (regulator-approved) information to patients, consumers and HCPs. For this
reason, therefore, we propose a phased approach, which starts with the creation, regulatory processing and dissemination
of electronic PLs and SmPCs, with the addition in later phases of other value-adding aspects of Product Information plus
corrective modifications (from post implementation learning) according to a mutually agreed roadmap.
This phased approach should include an analysis with relevant stakeholders, regarding additional information, including
from Annex II, which might be considered an added value for patients and HCPs. In this respect, it is proposed to focus on
regulatory communications which have an impact on patient care, e.g. risk minimisation materials.
A main key enabler for the adoption of ePI is a common standard that allows the generation and dissemination of
authorised information in the EU/EEA. In addition, we propose to stress the need for a common transmission standard
for the harmonised exchange of ePI between all stakeholders.
Features such as vocabularies and interoperability specifications are considered important for ePI and should be added
at inception because they are key for the specification of ePI.
The aims of the common standard are:
• to create the technical foundation for the dissemination of trustworthy, regulator-authorised product information and
• to offer possibilities to streamline, simplify and speed up the regulatory processes involved in the creation and updating
(variation) of PI, using existing data, such as SPOR (substance, product, organisation and referential) data, both by
regulators and the pharmaceutical industry
The programme for developing ePI must be aligned with all complimentary EU telematics projects including eCTD,
SPOR, TOM, CESP Dataset Module, and Regulatory Optimisation of Variations, and be strongly positioned in the
EU Network Strategy. ePI programme needs to be based on a solid governance model and attribution of roles and
responsibilities in ePI implementation.
There is a need for a robust milestone driven roadmap that is aligned with the different stakeholders and which is
based on agreed use cases. The roadmap should be drafted with high priority for the benefits of the patients; for that
reason, both new and existing products should be taken into account as part of the first milestone.
Therefore, from the design of ePI and its Roadmap implementation, it is crucial to start an open dialogue between Regulators
and industry, with the involvement of the Telematics Management Board, to understand how ePI will fit into the future
telematics ecosystem to ensure benefits for end-users. This includes preparatory work-plan for alignment on ‘definition’ and
identifying what business processes and telematics tools must be interconnected.
Industry has reached out for a strong collaboration between regulators and industry, with the involvement of the Telematics
Management Board (EMA – HMA – EC), to ensure we gain the efficiencies in the processes while being conscious of the
priority of bringing improvements in health information to patients and HCPs.
To achieve these key objectives and meet these expectations, urgent and adequate funding is required to underpin the
project work.
11CALL FOR ACTION:
• Start an open dialogue between regulators and industry, with the involvement of the Telematics Management
Board (EMA – HMA – EC), to understand how ePI will fit into the future telematics ecosystem to ensure benefits
for end-users. This includes preparatory work-plan for alignment on ‘definition’ and identifying what business
processes and telematics tools must be interconnected.
• Agreement on common standard that allows the generation and dissemination of authorised information in the
EU/EEA between relevant stakeholders.
• A proposal for an EU Implementation guideline elaborating on the concept of ePI, structured and unstructured
and re-usable elements should be developed collaboratively with relevant stakeholders and ultimately provided
by EMA.
• Additionally, when ePI will be implemented, the QRD templates could be updated to align content, technical,
design specifications and standard for both PI and ePI.
12Benefits for Public Health
The needs of the patients and HCPs (the ultimate end-users) must be at the forefront of the EC/EMA/HMA ePI
implementation strategy and approach
Industry believes that public health could benefit enormously from an ePI implementation in EU. Considering new advanced
technologies, we could and must go beyond the current scope proposed by the EMA key principles. There is a risk that
buy-in from patients/consumers might be relatively small, should ePI simply be provided for a small number of products
available on the market. Any implementation that is not coordinated across health authorities risks that some of the benefits
of ePI noted in the EMRN Strategy (e.g. in case of shortages) and in the EU Pharmaceutical Strategy20 cannot be achieved.
For that reason, industry support the EC vision of collaboration between Regulators, Members State and industry to
develop and implement ePI for all medicines in Europe.
Some examples of benefits and functionality that ePI will bring:
• The availability of ePI facilitates the immediate access to the most recently regulator-approved product information
and the ability to search and retrieve information in a more suitable and intuitive way.
• Additional information materials (video and audio facilities) to the statutory information21 available to EU citizens, that
will support and improve health literacy and inform on the correct use of the medicine. An attractive, presentable and
user-friendly interface with other potential supportive features motivate patients to take a more active interest in their health.
• In the case of chronic diseases, patients are so used to taking their medicines, that they do not read the leaflet anymore.
With ePI, an alert could be given in the event of a major update to the leaflet. This is of particular importance for
medicines that are already available on the market and used by patients.
However, ePI will not solve issues encountered due to poor compliance or low literacy per se. To address these latter
aspects, work on the statutory information (QRD template, readability etc.) and possible connection to other related
information such as instruction videos, audio content, additional information materials and risk minimisation
materials will need to take place in parallel. In addition, considerations need to be given on how user testing may need to
be adapted to take account of new formats.
Intuitive and straightforward access to ePI to enable an informed decision-making by patients, consumers and HCPs
In the ePI key principles document, it is envisaged that “ePI will be made available to users (e.g. patients/consumers and
HCPs) through websites at EMA level and if available, Member State level” and will be “also be available for use by third-
parties, who can reproduce ePI and make it available to patients and HCPs”.
We support the concept to have a single access-point to extract and re-use ePI as described in the Key principles –
process chart. Industry understands the value of ePI being available on a range of platforms throughout the EU but most
importantly each Member State must follow a coherent and consistent approach to develop and use ePI (from the point
of submission).In addition, it is critical to have a safe and secure access to the correct ePI from the medicinal pack. This
process should be intuitive and as simple as possible.
• Outer package: further discussion is needed in light of current and evolving technologies and standards, to facilitate
one code22 only on the (secondary) packaging to ensure clarity to patients, HCP and pharmacists and to avoid the risk of
mistakes and/or misunderstanding.
• The architecture of the web portal (and any other access point) must be structured in a way that patients are smoothly
and unequivocally directed to the right ePI, approved for that specific product. The Key principles suggest that “A pan-
European web portal could provide a central point for access of ePI for all centrally and nationally authorized medicines”.
This will ensure that patients are guaranteed to have access to a trusted source of regulator approved ePI.
• For those patients who cannot access their product information electronically, it has to be ensured that they can have the
same opportunity as the more digitally advanced patients to get the corresponding, most recent, regulator approved
product information printed in the pharmacy, at the point of sale or via other technologies.
• Educational campaign to raise awareness on this new way of accessing information is key to its widespread adoption
as part of the informed decision-making process.
20 https://ec.europa.eu/health/sites/health/files/human-use/docs/pharmastrategy_com2020-761_en.pdf
21 Include EMA guidance on Mobile scanning technologies as reference. https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/mobile-scanning-
other-technologies-labelling-package-leaflet-centrally-authorised-medicinal-products_en.pdf
22 A code can be achieved using different technology including but not limited to QR codes, 2D data matrix codes, linear barcodes.
13ePI Implementation and patients’ need
While industry recognises a need for allowing flexibility in implementation of ePI across EU countries, reflections should
be made on how to help countries with fewer resources, and lower digital skill capabilities for ePI implementation. In
addition, provisions should be given to support countries where access to digital information is less developed.
Provision of the latest information on a medicine’s safety, benefits and conditions of use
As long as the paper PL is required to be available, it should be taken into consideration that over a certain period of time,
there might be an “inconsistency” between the paper PL and the ePI, caused by the immediate availability of the ePI
while printing and packaging takes significantly longer. Therefore, as soon as ePI is introduced, the corresponding paper PL
should carry a standard sentence advising patients/consumers that the most current version of the product information
is provided by ePI with a note indicating how to access this information. Industry and authorities have to work together
to make sure that this sentence can be added in a pragmatic way to the paper leaflet and avoid any regulatory or
administrative burden for all stakeholders.
CALL FOR ACTION
• Patients must benefit from the full potential of new technologies; therefore, the ePI implementation roadmap
should cover all pharmaceutical products.
• Educational campaign to raise awareness on ePI as a new and improved way of accessing information. This is key
to its widespread adoption as part of the informed decision-making process.
• Industry and authorities to work on pragmatic implementation of a standardised sentence in the paper leaflet,
highlighting the existence of an ePI on reference websites, and avoid any regulatory or administrative burden to
the system.
• Discussion about current and evolving technologies and standards how to link to ePI in a long-term with only one
code on the (secondary) packaging.
• Architecture of the web portal (and any other access point) should be structured in a way that patients are
smoothly and unequivocally directed to the correct ePI, that is approved for that specific product.
• Obtain views, understanding of priorities, identify issues/areas of potential joint working or collaboration of all
stakeholders (patients, HCP, Industry, regulators) to define how the content of the PI can be improved.
• Reflections should be made on how to help countries with fewer resources and lower digital skill capabilities
for ePI implementation. In addition, provisions should be given to support countries where access to digital
information is less developed.
14Efficiency gains for regulatory systems
Regulatory efficiencies and operational excellence will be achieved for the benefit of Regulators and Industry via a coherent
and consistent implementation of ePI across Europe with significant consequential value for patients and Healthcare
providers. To achieve this, a common standard should be adopted in the creation, submission and review process and the
regulatory processes should leverage existing data of the TOM facilitated SPOR system.
There are excellent opportunities for efficiencies with ePI in the regulatory system through improved interoperability which
will ensure better accessibility and a high level of regulatory compliance (e.g. data from SPOR), by using structured and
semi-structured data. The main examples of these efficiencies relating to regulatory processes are:
• Automated Data filling from systems (SPOR, supported by TOM) for structured data.
• Controlled vocabulary for standardised information, e.g. patient friendly translations of scientific terms.
• Simplified introduction of referrals or health authority requested safety change outcomes.
• Potentially a longer implementation time for providing the updated paper leaflet in the box.
• Maintenance of text should be easier, only the relevant section of the PI needs to be updated.
• Changes made directly into systems, which will speed up the process for updates and approval of any change to the
ePI (e.g. change of pack size in SPOR, will automatically update ePI as well).
• Update of the QRD requirements should be reflected in the system, leading to possibility for an automatic update of
the ePI in accordance with the new version of the QRD, being ready for submission.
While being supportive of the implementation of ePI, the creation of ePI format for already existing PIs should equally
be prioritised by providing incentives i.e. an efficient process/guidance for the conversion of the current PI to the new ePI
format, process optimisation for changes to the PI, possible implementation without any regulatory submission/approval
process (if strict conversion) and there should be a reasonable transition time agreed with Industry.
CALL FOR ACTION
• Stronger collaboration between regulators and industry to establish the needs of both parties in regulatory
processes and submission management.
• Active involvement of the telematics network, to ensure processes are more efficient and linked to other relevant
telematics projects.
• Urgent and adequate funding is required, to accelerate the ePI development as highlighted by the recent COVID
pandemic and the regulatory and supply chain inefficiencies.
15Existing legislative framework
The EC Pharmaceutical Strategy23 formulates as an action to “develop and implement ePI for all EU medicines with involvements
of member states and industry” in addition it recognized the need to “evaluate and revise provisions in the legislation”. Industry
believes that ePI shall have the same value as paper PL, however this evolution requires further practical experience following
the implementation of ePI and should be considered as part of the evaluation of the legislation. However, a stepwise approach
needs to be developed, with relevant stakeholders, to ensure suitable and appropriate implementation occurs to safe-guard
patient needs.
There are situations where the paper PL could be removed from the pack and substituted by ePI while still ensuring
patients’ needs and interests are respected (e.g. by providing printed leaflet at point of dispensing).
Current practices with hospital / healthcare professional-administered products where patients rarely receive the
package leaflet, show there is no reason not to remove the paper leaflet from the pack. By directing patients toward the ePI it
will fill the gap of information that is a reality in today scenarios.
Therefore, industry proposes to expand current national pilot24 into a EEA-wide pilot study to investigate the current
practices and benefit of replacing paper with ePI for hospital/HCP administered products. Such a pilot could be expanded
to products directly dispensed to (and used by) patients in highly digitalised markets to investigate the current practices for
provision of information to patients and possible future alternatives such as the replacement of paper package leaflets with ePI
(or other alternatives, such as printing at pharmacy level).
Industry welcomes further discussion on additional ‘use cases’ that explore broader benefits of ePI considering:
• faster dissemination of relevant regulator approved changes to product information.
• mitigation of medicines shortages (by redistribution of packages in different languages as it was used in Germany for
flu-vaccination25).
• possible removal of the paper leaflet, starting in hospitals providing a positive outcome is seen from the Belgian pilot,
to reduce the volume of paper and ink currently used for the paper leaflet and contribute to the decrease of the carbon
footprint.
• reduced packaging/distribution and wastage costs (arising from implementation of safety changes and recall costs of
batches).
• quick access to the latest product information via ePI after the approval process, could enable a more flexible transitional
period for the provision of up-to-date paper leaflets.
• efficiencies in the size of packaging materials thereby reducing transport and storage space, (especially important for
products requiring controlled temperature storage).
CALL FOR ACTION
• Expansion of Pilot projects investigating the benefit of replacing paper with ePI for hospital/HCP
administered products.
• Supporting stakeholder discussions on additional ‘use cases’ and the positive benefits associated with them.
• Conduct legal framework analysis, to allow for the development of an ambitious ePI roadmap.
23 https://ec.europa.eu/health/sites/health/files/human-use/docs/pharmastrategy_com2020-761_en.pdf, pages 15 and 16.
24 More information available at the following links: https://www.afmps.be/fr/news/projet_pilote_e_pil_la_notice_papier_fait_place_a_la_notice_electronique; https://
pharma.be/fr/projects/e-pil-fr.html; The Ministère de la Santé in Luxembourg website https://sante.public.lu/fr/actualites/2020/08/e-pil-call-for-candidates/index.html
25 https://www.pei.de/DE/newsroom/hp-meldungen/2020/201028-vaxigrip-tetra-influenza-impfstoff-frankreich-eingefuehrt.
html;jsessionid=A430493D5264328B80407ABB09444254.2_cid354?nn=12248480
16Processes, flexibility and Governance
For a successful implementation of ePI across Europe for the interest of the patients, technology and process have a
crucial role to achieve the goals. The value of ePI is well recognised in the European Commission Pharmaceutical
Strategy26 as well as in the EMRN Strategy27, and to achieve the objectives set out in the Strategy a Plan for a coherent
and consistent EU implementation is needed. Currently there are more and more national health authorities’ initiatives
starting to be planned or implemented; this is a cause for concern for the industry because there is high risk that the major
benefits that patients can obtain, especially in a cross-border setting, will be missed because of lack of harmonised ePI
development and implementation. As pointed out in the EC pharmaceutical Strategy, Regulators, Members States and
industry need to collaborate to develop and implement ePI for all medicines in Europe.
Therefore, there is an urgent need to establish an open dialogue between regulators and industry on how ePI will fit
into the future telematics ecosystem to ensure benefits for all end-users (such as patients, HCPs and carers).
The Key Principles paper suggests that a broad margin of flexibility is given for national implementation of ePI across Europe.
However, if flexibility is not accompanied by a clear and binding phased roadmap and value-added milestones, the
consequence will be a fragmented and costly implementation process that will miss the opportunity for development of
optimal and common practices across the EU regulatory network. Variable timelines, together with multiple standards
and sources of information will undermine the main objective of providing updated and trustworthy product information to
patients and HCPs based on one authoritative source and to one EEA-wide standard.
A phased-approach roadmap should include a proof-of-concept phase in which the level of acceptable flexibility for an ePI
approach can be tested and improved accordingly.
Industry welcomes collaboration with the regulatory network to define the success criteria for a phased and meaningful
EU/ EEA-wide ePI implementation and would welcome an open dialogue to build an effective governance model.
Roles & responsibilities: Data-stewardship/accountability/liability
With regard to data stewardship28 of the content of the Product Information, clear assignment of responsibility is required
to clarify the accountability and liability for each step of the ePI process; in particular for the release of the ePI final content
that will be publicly available. We believe this openness will facilitate an efficient collaboration between Industry and
Regulator(s) in order to improve the governance aspect for ePI.
Industry is convinced that besides the data stewardship, also the data ownership should also be discussed. Dissemination
of trusted information via ePI to patients and HCPs is the primary objective and due to its digital nature and accessibility ePI
might be reproduced in various ways. While patients and HCPs are expected to benefit from well-controlled ePI services,
less controlled reuse of data and dissemination by third parties always comes with the risk that the reproduced data set is
not kept accurate e.g. when the data in the original source changes. Therefore, it needs to be clarified that such a scenario
is beyond the control of MAHs.
CALL FOR ACTION
For all the above considerations, industry has identified as crucial the following actions:
• Establish a central coordination of all “ePI like” initiatives, to ensure that key benefits to all stakeholders are delivered.
• Agree on Common Standard: A common standard should be developed in collaboration between the Industry,
Regulators and impacted stakeholders. Optimising the PI review process is important for timely updates to be
shared with the patients. Ensure the technical foundation of the ePI is designed with ease of implementation and
ease of maintenance in mind. The easier ePI is to implement, then the more likely MAH’s are to adopt the new
format. This will lead to a faster transition from the current unstructured PI’s to the structured ePI format.
• Identify a clear Governance structure and ownership of the ePI project that will ensure the appropriate funding for
a harmonised and coordinated implementation in all EU member States. The implementation phase of ePI should
have a clearly defined transition period and use cases that ePI will serve and an agreed binding Roadmap for the
implementation in all EU member States.
• Industry recommends having a transparent and open discussion, with the goal of confirming “data stewardship(s)
and data ownership(s)” of the content of ePI.
26 https://ec.europa.eu/health/sites/health/files/human-use/docs/pharmastrategy_com2020-761_en.pdf
27 https://www.ema.europa.eu/en/about-us/how-we-work/european-medicines-regulatory-network/european-medicines-agencies-network-strategy
28 “Data stewardship” of the content of the Product Information: the responsibilities for the paper leaflet are very clear: after approval of the final version, that text
should be included in the boxes of medicinal products. For Type IA changes, the MAH is allowed to make this change in the printed leaflet but has to notify the regulatory
authority of this change. The MAH is in this way always responsible and can be held liable for the leaflet that reaches the patient. This is considered “data stewardship”.
17Multilingual ePI
The availability of different official languages is accomplished by translations as part of the applicable EU regulatory procedure.
While PI for a centrally authorised medicine is available in all official EU languages (plus Norwegian and Icelandic), the PI for
a nationally authorised medicine is available in one or more official language(s) of the Member State where the medicine
is placed on the market. This means that for nationally authorised medicines interchangeability of language versions across
member states is not guaranteed by the frameworks applicable to this procedure.
For MRP or DCP procedures, ePI will be available in multiple languages but due to different timelines of national approvals,
they will not be available simultaneously. For those products, it should be permissible to provide links to other language
versions where interchangeability can be assured by the MAH.
The availability of ePI in multiple languages will facilitate the mitigation of medicines shortages enabling easier supply
without the need for relabelling. This is especially important in times of increased risk of medicines shortages as observed
with the COVID19 pandemic. As recognised in the EU Pharmaceutical strategy ePI can “support wider availability of
medicines across Member States”.
Broader use of multilingual packages could increase availability of medicines and improve management of the
supply chain. However, due to the challenges in providing printed paper leaflets in various languages in the final packaged
product, this is complex.
In particular, the limited space available to accommodate the multilingual text and lack of harmonisation of national
requirement for PI contents are the major challenges to implement Multilingual packages. For injectable medicines it is
even more complex to add languages in the paper leaflet, due to the size of the boxes that have to be as small as possible
to facilitate storage in refrigerated conditions.
ePI represents a game-changer tool to address those challenges, if individual EU / EEA member states will agree
to accept packaging potentially with one language only and have the other official approved language versions available
electronically. This would also facilitate the supply to small markets.
CALL FOR ACTION
We call for an open dialogue between industry and regulators on recognition of ePI as the main source in the
following scenarios:
• Mitigation of shortages by stock sharing between countries, without the need for repacking because the PL is
available as an ePI.
• Flexibility in language versions required in the paper leaflet for multilingual packs when the full text can be
provided in ePI.
• Possibility for use of packs from other markets to increase availability in small markets.
Removal of the paper leaflet and reliance on ePI as the single source will facilitate multi-country packs.
18Interoperability with EU and global initiatives
Industry warmly welcomes the ePI principle of interoperability by design with other ongoing initiatives in the digital
environment such as eHealth initiatives and EU Telematics projects and recommends including it as criterion for the design
and implementation of ePI from the start.
This will be essential to achieve significant objective for patients and HCPs such as alert of significant changes in the PI
content, like safety measures, but also to achieve efficiencies in the regulatory systems. SPOR data management service,
current electronic application procedures and national ePI systems represent the foundation of ePI for its effective
implementation.
In addition, it will be crucial to establish interoperability with cross-border prescription, electronic health records to ensure
effective functioning of the overall eHealth initiatives. In order to promote cross–border prescription, ePrescription and
support EU Citizens in managing their health abroad, connection between SPOR, ePI and eHealth initiatives is an essential
link.
CALL FOR ACTION
• ePI interoperable by design should be a successful criterion for its implementation, especially to connect and
transform regulatory processes and data into useful information provided to patients, consumers, HCPs and
caregivers.
• Recognise ePI as a part of the eHealth strategy.
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